• Perform a digital rectal exam (DRE)
  Confirm that prostate is normal in size, symmetrical in shape, and smooth in contour
• Monitor prostate-specific antigen (PSA) values
  Should be <4 ng/mL, or <3 ng/mL in men at high risk of prostate cancer, such as African Americans or men with first-degree relatives with prostate cancer
• Evaluate hematocrit levels
  Should be <50%

It is important to carefully evaluate patients receiving testosterone replacement therapy at baseline and monitor their status throughout treatment.¹ The following guidelines can assist you in monitoring your patients' progress:

Urological consultation recommended if:

• An increase in serum or plasma PSA^† concentration greater than 1.4 ng/mL within any 12-month period of testosterone treatment^‡
• A PSA velocity of more than 0.4 ng/mL per year using the PSA level after 6 months of testosterone administration as the reference^§
• A prostatic abnormality is detected upon DRE (digital rectal examination)

Stop therapy if at any point during treatment hematocrit levels exceed 54%. Do not resume therapy until levels decrease to a safe level.

^*Values may differ by laboratory. Clinicians should use the lower limit of normal range for healthy young men established in their selected laboratory.

^†PSA=prostate-specific antigen.

^‡Used for evaluating any 1-year period after initiation of testosterone therapy.

^§PSA velocity should be used only if there are longitudinal PSA data for more than 2 years.

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Androgens are contraindicated in men with cancer of the breast or known or suspected cancer of the prostate. Testim is not indicated for women and must not be used in women. Pregnant and nursing women should avoid skin contact with Testim application sites on men. Testosterone may cause fetal harm, or harm a breast-feeding baby.

Testim should not be used in patients with known hypersensitivity to testosterone or any of the ingredients in Testim, including soy.

Men treated with androgens may be at an increased risk for prostate cancer, or the development or worsening of benign prostatic hyperplasia.

Testim is not meant for use in women. If you are pregnant, may become pregnant, or are breast-feeding, Testim may harm your unborn or breast-feeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area where Testim has been applied.